Efficacy and Safety of Xueshuanxinmaining Tablet for the Treatment of Stable Angina Pectoris

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status and phase: Unknown; Phase 4

Conditions: Coronary Heart Disease; Stable Angina

Treatments: Drug: Nitroglycerin tablets; Drug: Xueshuanxinmaining tablet; Drug: Xueshuanxinmaining placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04270279

XSXMN_2019001

Details and patient eligibility

About

This study is a randomized, double-blind, placebo-controlled, parallel clinical trial in Chinese population with stable angina pectoris. The purpose is to determine the efficacy and safety of Xueshuanxinmaining tablet in the treatment of stable angina pectoris.

Full description

Xueshuanxinmaining tablet is a Chinese patent medicine composed of Ligusticum chuanxiong, Salvia miltiorrhiza, borneol and Toad puff, etc. It has been widely used in cardiovascular diseases in China. Clinical application suggested that Xueshuanxinmaining tablet was safe and effective in the treatment of stable angina pectoris. However, it still needs to be further confirmed by high-quality, large sample randomized controlled trials. This randomized, double-blind, placebo-controlled clinical trial is to determine the efficacy and safety of Xueshuanxinmaining tablet in the treatment of stable angina pectoris.

Enrollment: 120 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants are aged between 40 and 75 years.
• Meet the diagnostic criteria of stable angina pectoris.
• Meet Chinese medicine syndrome differentiation of Qi-yin deficiency and blood stasis syndrome.
• Voluntarily participate and sign informed consent.

Exclusion criteria

• Patients were diagnosed as acute myocardial infarction, unstable angina, stable exertion angina and other heart diseases.
• Patients with poor control of hypertension and diabetes, severe cardiopulmonary insufficiency, severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.), with a history of heart pacemaker or cerebrovascular disease within one year.
• Any of the following disease history or evidence was found in the screening period: severe cardiovascular or cerebrovascular diseases; active, recurrent peptic ulcer or other bleeding risk diseases; other serious diseases of digestive system; combined with malignant tumor, blood system disease, serious or progressive diseases of the other system; combined with mental diseases.
• Before screening, any laboratory inspection index meets the following standards: The results showed that Glutamic aspartate transaminase (AST) or alanine aminotransferase (ALT) were more than 1.5 times of the upper limit of normal value and serum creatinine (Cr) was more than 1.2 times of the upper limit of normal value.
• With a history of alcohol and drug abuse.
• Pregnant or lactating women.
• Patients who have participated in clinical trials of other drugs within 3 months before enrollment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Xueshuanxinmaining Tablet

Experimental group

Description:

Patients were given Xueshuanxinmaining tablet orally 2 pills each time, 3 times daily for 8 weeks. And patients can take nitroglycerin tablets provided by the sponsor when angina attack. For patients who have used drugs such as aspirin, angiotensin-converting enzyme inhibitor, lipid-lowering drugs to treat coronary heart disease before inclusion, they can continue to use the original varieties and doses, without dose adjustment.

Treatment:

Drug: Nitroglycerin tablets

Drug: Xueshuanxinmaining tablet

Placebo

Placebo Comparator group

Description:

Patients were given Xueshuanxinmaining tablet simulation orally 2 pills each time, 3 times daily for 8 weeks. And patients can take nitroglycerin tablets provided by the sponsor when angina attack. For patients who have used drugs such as aspirin, angiotensin-converting enzyme inhibitor, lipid-lowering drugs to treat coronary heart disease before inclusion, they can continue to use the original varieties and doses, without dose adjustment.

Treatment:

Drug: Nitroglycerin tablets

Drug: Xueshuanxinmaining placebo